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Downstream Process Engineer II - Night Shift

Employer
Thermo Fisher Scientific
Location
Saint Louis, MO
Closing date
Oct 1, 2021

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When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.
How will you make an impact
The Downstream Process Engineer is an expert (dependent on level) in his/her field of expertise (downstream processing) and is regarded as such within Thermo Fisher Scientific. The Process Engineer provides technological input in the transfer and development of a process and is the technical owner while running customer programs in clinical manufacturing. He/She also contributes to defining and shaping Thermo Fisher Scientific's own technology programs.
This role will work in close collaboration with customers, supervisors and technicians in the Operations department, QA, other Engineers, line management, and scientists in PD. These activities are executed in projects, and involve teamwork with representatives of various to ensure project success.
This position's work schedule requires the incumbent to work evening and midnight hours in support of a 24/7 commercial operations. What will you do * Work with process development to define common methodologies for conducting unit operations at the manufacturing scale. Typical manufacturing operations include chromatography, ultrafiltration, and depth filtration.
* Represent Process Engineering in Internal and Customer meetings and make sound evidence-based contributions.
* Manage projects with supervisor oversight
* Actively drive engineering initiatives to improve practices and procedures
* Provide technical support for GMP deviations. Help devise and Implement Corrective Actions.
* Implement changes to equipment and processes
* Document procedures via Process Flow Diagrams, Standard Operation Procedures, and Job Aids.
* Draft and own Manufacturing Batch Records ensuring the process is technically accurate and Designed for Manufacturing
* Review and provide technical oversight on documents created by other departments, such as Tech Transfer Protocols and SOPs
* Provide on-floor technical support for manufacturing processing, as needed.
* Additional tasks to support MSAT team
How will you get here
Education * Bachelor's degree required in a scientific field, preferably an engineering field.
Experience * 2+ years of experience in GMP regulated Biologics / Pharma Industry
* Adhere to Environmental Health and Safety policies and procedures and ensure a safe and healthy workplace environment
* Ability to self-motivate, prioritize work and time
* Demonstrates a solid foundation in general scientific practices, principals and concepts
* Strong written and oral communication skills.
* Ability to work both independently and in a team environment
* Knowledge of current Good Manufacturing Practices and US/EU regulations.
* Proficient in Microsoft Word and Excel.
At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission""enabling our customers to make the world healthier, cleaner and safer.
Apply today! [Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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